Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The most commonly observed adverse events of NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.

Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions.
The most frequent adverse effects of lornoxicam include nausea, dyspepsia, indigestion, abdominal pain, vomiting, and diarrhea. These symptoms have generally occurred in less than 10% of patients in available studies.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Listed below are undesirable effects which generally occurred in more than 0.05% of the 6.417 patients treated in clinical phase II, III and IV trials.
Very common (1/10); Common (1/100, <1/10); Uncommon (1/1000, <1/100); rare (1/10.000, <1/1.000); Very rare (<1/10.000), not known (cannot be estimated from the available data) 
Infections and infestations
Rare: Pharyngitis.

Blood and the lymphatic system disorders
Rare: Anaemia, thrombocytopenia, leucopoenia, prolonged bleeding time Very rare: Ecchymosis. NSAIDs have been reported to cause potentially severe hematological disorders like neutropenia, agranulocytosis, aplastic anaemia, and hemolytic anaemia as class effects..

Immune system disorders
Rare: Hypersensitivity, anaphylactoid reaction, anaphylaxis

Metabolism and nutrition disorders
Uncommon: Anorexia, weight changes.
Psychiatric disorders
Uncommon: Insomnia, depression.
Rare: Confusion, nervousness, agitation.


Nervous system disorders
Common: Mild and transient headache, dizziness.
Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.
Very rare: Aseptic meningitis in patients with SLE and mixed connective tissue disorder (see 4.4).
Eye disorders
Uncommon: Conjuctivitis
Rare: Visual disturbances.

Ear and labyrinth disorders

Uncommon: Vertigo, tinnitus.
Cardiac disorders
Uncommon: Palpitations, tachycardia, oedema, cardiac failure.

Vascular disorders
Uncommon: Flushing, oedema.
Rare: Hypertension, hot flush, haemorrhage, haematoma.

Respiratory, thoracic and mediastinal disorders
Uncommon: Rhinitis.
Rare: Dyspnoea, cough, bronchospasm.
Gastrointestinal disorders
Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.
Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer, gastrointestinal hemorrhage.

Hepatobiliary disorders
Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).
Very rare: Hepatotoxicity resulting in e.g. hepatic failure, hepatitis, jaundice and cholestasis.

Skin and subcutaneous tissue disorders
Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria, angioedema and alopecia, dermatitis, ecchymoses.
Rare: Dermatitis and eczema, purpura.
Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis 
Musculoskeletal and connective tissue disorders
Uncommon: Arthralgia
Rare: Bone pain, muscle spasms, myalgia.

Renal and urinary disorders
Rare: Nocturia, micturition disorders, increase in blood urea nitrogen and creatinine levels.
Very rare: Lornoxicam may precipitate acute renal failure in patients with pre-existing renal impairment, who are dependent on renal prostaglandins for maintenance of renal blood flow (see 4.4). Nephrotoxicity in various forms including nephritis and nephrotic syndrome has been associated with NSAIDs as class effect.

General disorders and administration site conditions
Uncommon: Malaise, face oedema
Rare: Asthenia.